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The purpose of the CardioMEMS CED Study is to determine if pulmonary artery (PA) pressure-guided heart failure management using the CardioMEMSâ„¢ HF System improves long-term health outcomes in heart failure (HF) patients in the real-world setting.
The CardioMEMS CED Study will assess 2-year HF hospitalization rates and survival for all-cause mortality in heart failure subjects managed with the CardioMEMS HF system, as compared to a contemporaneous control of HF subjects managed without PA pressure-guidance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Heart failure patients implanted with the CardioMEMS PA pressure sensor. |
| |
| Control Group | Heart failure patients being managed without PA pressure-monitoring. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CardioMEMS HF System | Device | PA Pressure Sensor |
|
| Measure | Description | Time Frame |
|---|---|---|
| HF Hospitalization Rate. | Compare HF hospitalization rate between the treatment and control groups. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Two-Year Survival | Compare survival between the treatment and control groups. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will include Heart Failure patients in the United States implanted with the CardioMEMS PA pressure sensor and HF patients being managed without PA pressure-monitoring.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nessa Johnson | Contact | 612-283-3865 | nessa.johnson@abbott.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abbott | Recruiting | Pleasanton | California | 94588 | United States |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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